Clinical management Protocol and Infection Control Guidelines

DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH AND FAMILY WELFARE GOVT OF INDIA

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Swine Flu

Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India
Swine Influenza

Clinical Management Protocol

1. Introduction

As on 30.04.09, 148 laboratory confirmed human cases of Swine influenza A (H1N1) has been reported from nine countries with 8 deaths. ( Mexico [26 cases, 7 deaths], USA [91 cases, one death], Canada (13), Austria(1), Germany (3), Israel(2), New Zealand (3), Spain(4), and United Kingdom (5). Over 1300 suspected cases have been reported with about 100 deaths. The outbreak started in Mexico on 18th March, 2009 and spread to USA and Canada and then to other countries.

WHO has heightened the pandemic level to Phase 5 implying widespread human infection.

2. Epidemiology

2.1 The agent

Genetic sequencing shows a new sub type of influenza A (H1N1) virus with segments from four influenza viruses: North American Swine, North American Avian, Human Influenza and Eurasian Swine.

2.2 Host factors

The majority of these cases have occurred in otherwise healthy young adults.

2.3 Transmission

The transmission is by droplet infection and fomites.

2.4 Incubation period

1-7 days.

2.5 Communicability

From 1 day before to 7 days after the onset of symptoms. If illness persist for more than 7 days, chances of communicability may persist till resolution of illness. Children may spread the virus for a longer period.

There is substantial gap in the epidemiology of the novel virus which got re-assorted from swine influenza.

3. Clinical features

Important clinical features of swine influenza include fever, and upper respiratory symptoms such as cough and sore throat. Head ache, body ache, fatigue diarrhea and vomiting have also been observed.

There is insufficient information to date about clinical complications of this variant of swine origin influenza A (H1N1) virus infection. Clinicians should expect complications to be similar to seasonal influenza: sinusitis, otitis media, croup, pneumonia, bronchiolitis, status asthamaticus, myocarditis, pericarditis, myositis, rhabdomyolysis, encephalitis, seizures, toxic shock syndrome and secondary bacterial pneumonia with or without sepsis. Individuals at extremes of age and with preexisting medical conditions are at higher risk of complications and exacerbation of the underlying conditions.

The reporting of cases is to be based on the case definition provided (Annexure-I).

4. Investigations

Routine investigations required for evaluation and management of a patient with symptoms as described above will be required. These may include haematological, biochemical, radiological and microbiological tests as necessary.
Confirmation of influenza A(H1N1) swine origin infection is through:

Real time RT PCR or
Isolation of the virus in culture or
Four-fold rise in virus specific neutralizing antibodies.

For confirmation of diagnosis, clinical specimens such as nasopharyngeal swab, throat swab, nasal swab, wash or aspirate, and tracheal aspirate (for intubated patients) are to be obtained. The sample should be collected by a trained physician / microbiologist preferably before administration of the anti-viral drug. Keep specimens at 4°C in viral transport media until transported for testing. The samples should be transported to designated laboratories with in 24 hours. If they cannot be transported then it needs to b stored at -70°C. Paired blood samples at an interval of 14 days for serological testing should also be collected.

5. Treatment

The guiding principles are:

Early implementation of infection control precautions to minimize nosocomical / household spread of disease
Prompt treatment to prevent severe illness & death.
Early identification and follow up of persons at risk.

5.1 Infrastructure / manpower / material support

Isolation facilities: if dedicated isolation room is not available then patients can be cohorted in a well ventilated isolation ward with beds kept one metre apart.
Manpower: Dedicated doctors, nurses and paramedical workers.
Equipment: Portable X Ray machine, ventilators, large oxygen cylinders, pulse oxymeter
Supplies: Adequate quantities of PPE, disinfectants and medications (Oseltamivir, antibiotics and other medicines)

5.2 Standard Operating Procedures

Reinforce standard infection control precautions i.e. all those entering the room must use high efficiency masks, gowns, goggles, gloves, cap and shoe cover.
Restrict number of visitors and provide them with PPE.
Provide antiviral prophylaxis to health care personnel managing the case and ask them to monitor their own health twice a day.
Dispose waste properly by placing it in sealed impermeable bags labeled as Bio- Hazard.

5.3 Oseltamivir Medication

Oseltamivir is the recommended drug both for prophylaxis and treatment.

It is also available as syrup (12mg per ml)
If needed dose & duration can be modified as per clinical condition.

Adverse reactions:

Oseltamivir is generally well tolerated, gastrointestinal side effects (transient nausea, vomiting) may increase with increasing doses, particularly above 300 mg/day. Occasionally it may cause bronchitis, insomnia and vertigo. Less commonly angina, pseudo membranous colitis and peritonsillar abscess have also been reported. There have been rare reports of anaphylaxis and skin rashes. In children, most frequently reported side effect is vomiting. Infrequently, abdominal pain, epistaxis, bronchitis, otitis media, dermatitis and conjunctivitis have also been observed. There is no recommendation for dose reduction in patients with hepatic disease. Though rare reporting of fatal neuro-psychiatiric illness in children and adolescents have been linked to oseltamivir, there is no scientific evidence for a causal relationship.

5.4 Supportive therapy

Paracetamol or ibuprofen is prescribed for fever, myalgia and headache. Patient is advised to drink plenty of fluids. Smokers should avoid smoking. For sore throat, short course of topical decongestants, saline nasal drops, throat lozenges and steam inhalation may be beneficial.

Salicylate / aspirin is strictly contra-indicated in any influenza patient due to its potential to cause Reye’s syndrome.
The suspected cases would be constantly monitored for clinical / radiological evidence of lower respiratory tract infection and for hypoxia (respiratory rate, oxygen saturation, level of consciousness).

Patients with signs of tachypnea, dyspnea, respiratory distress and oxygen saturation less than 90 per cent should be supplemented with oxygen therapy. Types of oxygen devices depend on the severity of hypoxic conditions which can be started from oxygen cannula, simple mask, partial re-breathing mask (mask with reservoir bag) and non re-breathing mask. In children, oxygen hood or head boxes can be used.

Patients with severe pneumonia and acute respiratory failure (SpO2 < 90% and PaO2 <60 mmHg with oxygen therapy) must be supported with mechanical ventilation. Invasive mechanical ventilation is preferred choice. Non invasive ventilation is an option when mechanical ventilation is not available. To reduce spread of infectious aerosols, use of HEPA filters on expiratory ports of the ventilator circuit / high flow oxygen masks is recommended.

If the laboratory reports are negative, the patient would be discharged after giving full course of oseltamivir. Even if the test results are negative, all cases with strong epidemiological criteria need to be followed up.
Immunomodulating drugs has not been found to be beneficial in treatment of ARDS or sepsis associated multi organ failure. High dose corticosteroids in particular have no evidence of benefit and there is potential for harm. Low dose corticosteroids (Hydrocortisone 200-400 mg/ day) may be useful in persisting septic shock (SBP < 90).

Suspected case not having pneumonia do not require antibiotic therapy. Antibacterial agents should be administered, if required, as per locally accepted clinical practice guidelines. Patient on mechanical ventilation should be administered antibiotics prophylactically to prevent hospital associated infections.

5.5 Discharge Policy

Adult patients should be discharged 7 days after symptoms have subsided.
Children should be discharged 14 days after symptoms have subsided.
The family of patients discharged earlier should be educated on personal hygiene and infection control measures at home; children should not attend school during this period.

5.6 Chemo Prophylaxis

All close contacts of suspected, probable and confirmed cases. Close contacts include household /social contacts, family members, workplace or school contacts, fellow travelers etc.
All health care personnel coming in contact with suspected, probable or confirmed cases
Oseltamivir is the drug of choice.
Prophylaxis should be provided till 10 days after last exposure (maximum period of 6 weeks)

For infants:
< 3 months not recommended unless situation judged critical due to limited data on use in this age group
3-5 months - 20 mg OD
6-11 months - 25 mg OD

5.7 Non-Pharmaceutical Interventions

Close Contacts of suspected, probable and confirmed cases should be advised to remain at home (voluntary home quarantine) for at least 7 days after the last contact with the case. Monitoring of fever should be done for at least 7 days. Prompt testing and hospitalization must be done when symptoms are reported.h4.
All suspected cases, clusters of ILI/SARI cases need to be notified to the State Health Authorities and the Ministry of Health & Family Welfare, Govt. of India (Director, EMR and NICD)

6. Laboratory Tests

The samples are to be tested in BSL-3 laboratory. At present the following laboratories are the identified laboratories for this purpose:(i) National Institute of Communicable Diseases, 22, Sham Nath Marg, Delhi [Tel. Nos. Influenza Monitoring Cell: 011-23921401; Director: 011-23913148] (ii) National Institute of Virology, 20-A, Dr. Ambedkar Road, Pune-411001 [Tel.No. 020-26124386]

Guidelines on Infection control Measures

Infection control measures would be targeted according to the risk profile as follows:

1. Health facility managing the human cases of avian influenza

1.1 During Pre Hospital Care

Standard precautions are to be followed while transporting patient to a health-care facility. The patient should also wear a three layer surgical mask.
Aerosol generating procedures should be avoided during transportation as far as possible.
The personnel in the patient’s cabin of the ambulance should wear full complement of PPE including N95 masks, the driver should wear three layered surgical mask.
Once the patient is admitted to the hospital, the interior and exterior of the ambulance and reusable patient care equipment needs to be sanitized using sodium hypochlorite / quaternary ammonium compounds.
Recommended procedures for disposal of waste (including PPE used by personnel) generated in the ambulance while transporting the patient should be followed.

1.2 During Hospital Care

The patient should be admitted directly to the isolation facility and continue to wear a three layer surgical mask.
The identified medical, nursing and paramedical personnel attending the suspect/ probable / confirmed case should wear full complement of PPE (including N95 mask). If splashing with blood or other body fluids is anticipated, a water proof apron should be worn over the PPE.

Aerosol-generating procedures such as endotracheal intubation, nebulized medication administration, induction and aspiration of sputum or other respiratory secretions, airway suction, chest physiotherapy and positive pressure ventilation should be performed by the treating physician/ nurse wearing full complement of PPE with N95 respirator on.
Sample collection and packing should be done under full cover of PPE.

Perform hand hygiene before and after patient contact and following contact with contaminated items, whether or not gloves are worn.

Until further evidence is available, infection control precautions should continue in an adult patient for 7 days after resolution of symptoms and 14 days after resolution of symptoms for children younger than 12 years because of longer period of viral shedding expected in children. If the patient insists on returning home, after resolution of fever, it may be considered, provided the patient and household members follow recommended infection control measures and the cases could be monitored by the health workers in the community.

The virus can survive in the environment for variable periods of time (hours to days). Cleaning followed by disinfection should be done for contaminated surfaces and equipments.

The virus is inactivated by a number of disinfectants such as 70% ethanol, 5% benzalkonium chloride (Lysol) and 10% sodium hypochlorite. Patient rooms/areas should be cleaned at least daily and finally after discharge of patient. In addition to daily cleaning of floors and other horizontal surfaces, special attention should be given to cleaning and disinfecting frequently touched surfaces. To avoid possible aerosolization of the virus, damp sweeping should be performed. Horizontal surfaces should be dusted by moistening a cloth with a small amount of disinfectant.

Clean heavily soiled equipment and then apply a disinfectant effective against influenza virus (mentioned above) before removing it from the isolation room/area. If possible, place contaminated patient-care equipment in suitable bags before removing it from the isolation room/area.

When transporting contaminated patient-care equipment outside the isolation room/area, use gloves followed by hand hygiene. Use standard precautions and follow current recommendations for cleaning and disinfection or sterilization of reusable patient-care equipment.

All waste generated from influenza patients in isolation room/area should be considered as clinical infectious waste and should be treated and disposed in accordance with national regulations pertaining to such waste. When transporting waste outside the isolation room/area, gloves should be used followed by hand hygiene.

Annexure I

Case Definition

A suspected case of swine influenza A (H1N1) virus infection is defined as a person
with acute febrile respiratory illness (fever ≥38 0°C) with onset.:
within 7 days of close contact with a person who is a confirmed case of swine influenza A (H1N1) virus infection, or
within 7 days of travel to community where there are one or more confirmed swine influenza A(H1N1) cases, or
resides in a community where there are one or more confirmed swine influenza cases.
A probable case of swine influenza A (H1N1) virus infection is defined as a person with an acute febrile respiratory illness who:

is positive for influenza A, but unsubtypable for H1 and H3 by influenza RT-PCR or reagents used to detect seasonal influenza virus infection, or
is positive for influenza A by an influenza rapid test or an influenza immunofluorescence assay (IFA) plus meets criteria for a suspected case
individual with a clinically compatible illness who died of an unexplained acute respiratory –illness who is considered to be epidemiologically linked to a probable or confirmed case.
A confirmed case of swine influenza A (H1N1) virus infection is defined as a person with an acute febrile respiratory illness with laboratory confirmed swine influenza A (H1N1) virus infection at WHO approved laboratories by one or more of the following tests:

Once outside room use alcohol hand-rub again or wash hands with soap and water.

Used PPE should be handled as waste as per waste management protocol

Annexure III

Guidelines/ operating procedures for infection control practices

1. Infection control measures at Individual level
1.1 Hand Hygiene

Hand hygiene is the single most important measure to reduce the risk of transmitting infectious organism from one person to other.

Hands should be washed frequently with soap and water / alcohol based hand rubs/ antiseptic hand wash and thoroughly dried preferably using disposable tissue/ paper/ towel.

After contact with respiratory secretions or such contaminated surfaces.
Any activity that involves hand to face contact such as eating/ normal grooming / smoking etc.

Steps of hand washing

Step 1.Wash palms and fingers.

Step 2.Wash back of hands.

Step 3. Wash fingers and knuckles.

Step 4.Wash thumbs.

Step 5.Wash fingertips.

Step 6.Wash wrists.

1.2 Respiratory Hygiene/Cough Etiquette

The following measures to contain respiratory secretions are recommended for all individuals with signs and symptoms of a respiratory infection.

Cover the nose/mouth with a handkerchief/ tissue paper when coughing or sneezing;
Use tissues to contain respiratory secretions and dispose of them in the nearest waste receptacle after use;
Perform hand hygiene (e.g., hand washing with non-antimicrobial soap and water, alcohol-based hand rub, or antiseptic hand wash) after having contact with respiratory secretions and contaminated objects/materials

1.3 Staying away

Stay away from poultry. Keep them secure in cages. Keep children out of reach.
Wash hands if in contact with poultry or poultry products.
Stay at least one metre away from a person having cough or sneeze.

1.4 Use of mask

As there is no efficient human to human transmission in phase III, masks are not recommended for individuals or community. As a matter of abundant precaution, PUI/ suspected cases managed at home and there family contacts are trained on using three layered surgical masks.

Advise healthcare personnel to observe Droplet Precautions (i.e., wearing a surgical or procedure masks for close contact), in addition to Standard Precautions, when examining a patient with symptoms of a respiratory infection, particularly if fever is present. These precautions should be maintained until it is determined that the cause of symptoms is not an infectious agent that requires Droplet Precautions.

2.2 Visual Alerts

Post visual alerts (in appropriate languages) at the entrance to outpatient facilities (e.g., emergency departments, physician offices, outpatient, clinics) instructing patients and persons who accompany them (e.g., family, friends) to inform healthcare personnel of symptoms of a respiratory infection when they first register or care and to practice Respiratory Hygiene/Cough Etiquette.

2.3 Use of PPE

The medical, nurses and paramedics attending the suspect/ probable / confirmed case should wear full complement of PPE (Annexure-IX).
Use N-95 masks during aerosol-generating procedures.
Perform hand hygiene before and after patient contact and following contact with contaminated items, whether or not gloves are worn.
Sample collection and packing should be done under full cover of PPE.

2.4 Decontaminating contaminated surfaces, fomites and equipments

Cleaning followed by disinfection should be done for contaminated surfaces and equipments.
use phenolic disinfectants, quaternary ammonia compounds , alcohol or sodium hypochlorite. Patient rooms/areas should be cleaned at least daily and terminally after discharge. In addition to daily cleaning of floors and other horizontal surfaces, special attention should be given to cleaning and disinfecting frequently touched surfaces.
To avoid possible aerosolization of AI virus, damp sweeping should be performed.
Clean heavily soiled equipment and then apply a disinfectant effective against influenza virus before removing it from the isolation room/area.

When transporting contaminated patient-care equipment outside the isolation room/area, use gloves followed by hand hygiene. Use standard precautions and follow current recommendations for cleaning and disinfection or sterilization of reusable patient-care equipment.

2.5 Guidelines for waste disposal

All the waste has to be treated as infectious waste and decontaminated as per standard procedures
Articles like swabs/gauges etc are to be discarded in the Yellow coloured autoclavable biosafety bags after use, the bags are to be autoclaved followed by incineration of the contents of the bag.
Waste like used gloves, face masks and disposable syringes etc are to be discarded in Blue/White autoclavable biosafety bags which should be autocalaved/microwaved before disposal
All hospitals and laboratory personnel should follow the standard guidelines (Biomedical waste management and handling rules, 1998) for waste management.